To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.

For details on how to find us please click here.

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What's New in eSubmission Today?

29-04-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.3 released to production on 28 April 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

Please note that a small number of products are affected by a synchronisation issue with PMS and the forms where they are used cannot be exported and finalised. Once added the products in the eAF, export the form and should you see the message "Data refresh cannot be completed. Aborting the operation. Please retry again", please use the interactive PDF instead. The teams are working on fixing this issue and a new message will be published once it is resolved.

And

Planned maintenance of eSubmission systems on 30 April 2025, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Wednesday 30 April 2025, between 18:00 and 20:00: eSubmission website, PSUR Repository, Gateway Filehandler, Delivery File UI, Registration Gateway.

For any further information, please contact EMA Service Desk.

28-04-2025

Reminder for PSUSA procedures: new requirement for Word version of the initial PSURs and RSI responses

When submitting initial PSUR or RSI responses for a PSUSA procedure, the marketing authorisation holders (MAHs) are also required to systematically provide Word versions of the submitted initial PSURs and RSI responses, as part of the Working Documents folder.

When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.

Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence "0007", which contains working documents, the separate folder should be named "0007-workingdocuments".

More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0

25-04-2025

eAF v1.27.0.1 (Human Variation) now available, for use from 1 May 2025

A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website. The version can be used starting with 1^st of May 2025. The version allows the selection of Reference Member State and Concerned Member State(s) when the type of authorisation is 'National Authorisation' and the type of application is 'Super-grouping'.

It is mandatory to use version 1.27.0.1 for all new Human Variation procedures. The version 1.27.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for ongoing procedures. Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

16-04-2025

PSUSA procedures: new requirement for Word version of the PSURs and RSI responses

When submitting PSUR or RSI responses for a PSUSA procedure, the marketing authorisation holders (MAHs) are also required to systematically provide Word versions of the submitted PSURs and RSI responses, as part of the Working Documents folder.

Reminder
When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.

Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence "0007", which contains working documents, the separate folder should be named "0007-workingdocuments". More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0.

More details can be found in chapter 2.9.10 of the Harmonised guidance eCTD - version 6.0.

And

Planned maintenance of eSubmission systems on 23 April 2025, 18:00 CET

Due to planned maintenance, the Common Repository Web User Interface and API (relevant for NCAs only) and the PSUR Repository Industry access and NCA access will not be available on Wednesday 23 April 2025, between 18:00 and 20:00. For any further information, please contact EMA Service Desk.

04-04-2025

Update on web-based Human variations electronic Application Forms (eAFs) timeline

EMA would like to provide you with an update on the progress of the web-based Human variations electronic Application Form (eAF) implementation on the Product Lifecycle Management (PLM) Portal.

During Q1 2025, we announced that the human variation web-based eAF was open for first use for non-Centrally Authorised Products (non-CAPs) through the PLM Portal, allowing Marketing Authorisation Holders to use the web-based application form for all EU variation procedures, including submission to the NCAs.

Key points of the updated timeline:
Q2 2025:

• Recommended use of Human variation eAF for non-CAPs*.
• Continue the incremental release of the new UX design and the incremental release of new features, including maintenance and optimisation updates and performance improvements.

Q3 & Q4 2025:

• Strongly Recommended use of Human variation eAF for non-CAPs*.
• Exploration of structured changes in eAF.

Please send any questions or concerns to PLM.ValueStream@ema.europa.eu

*Exact date to be defined, on the condition that no major issues are identified

03-04-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.2 released to production on 31 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

02-04-2025

eCTD 3.2.2 - validation criteria 8.1 to be updated

In the most recent validation criteria (version 8.1) for EU eCTD M1 specification, the rules 15.11 and 15.12 referring to the tracking table being mandatory for all submission types were updated. However, these rules do not apply to EDQM submissions; a new version of the EU eCTD M1 package will be published at a later stage.

In the meantime, for EDQM submissions, you can submit the packages even if the validation does not pass for rules 15.11 and 15.12.

28-03-2025

Planned maintenance of eSubmission systems on 31 March 2025, 18:00 CET

Due to planned maintenance and the activation of the Common Repository API MFA, the Common Repository Web User Interface and API (relevant for NCAs only) will not be available on Monday 31 March 2025, between 18:00 and 22:00.

For any further information, please contact EMA Service Desk.

25-03-2025

Updated PLM Portal eAF guide to navigation now available

An updated version of the PLM Portal eAF guide to navigation is now available.

19-03-2025

Planned maintenance of eSubmission systems on 24 March 2025, 18:00 CET

Due to planned maintenance, the Common Repository Web User Interface and API (relevant for NCAs only) and PSUR Repository Web User Interface and API (relevant for NCAs only) will not be available on Monday 24 March 2025, between 18:00 and 22:00

For any further information, please contact EMA Service Desk.

19-03-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.1 released to production on 17 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

14-03-2025

Planned maintenance of eSubmission systems on 17 March 2025, 18:00 CET

Due to planned maintenance, the Common Repository Web User Interface and API (relevant for NCAs only) and PSUR Repository Web User Interface and API (relevant for NCAs only) will not be available on Monday 17 March 2025, between 18:00 and 22:00

For any further information, please contact EMA Service Desk.

07-03-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.0 released to production on 06 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

And

Planned maintenance of PSUR Repository API on 7 March 2025, 18:00 CET

Due to planned maintenance, the PSUR Repository API (relevant for NCAs only) will not be available on Friday 7 March 2025, between 18:00 and 19:00.

For any further information, please contact EMA Service Desk.

05-03-2025

PLM Portal eAF – Integrity stamp go-live on 6 March

EMA is pleased to announce that the PLM Portal eAF Integrity stamp feature will be deployed Thursday, 6th of March, after 18:00 CET.

The main impact and changes are as follows:

• Upon 'Finalisation', the PLM Portal web based human variation eAF will be locked and moved to the 'Completed' tab (the form can be opened for further editing if necessary)
• The form will be locked with a digital 'signature' called eAF integrity warranty (or eAF integrity stamp)
• Will be launched on 6th March 2025 – after this date the system will include the stamp on all forms that are finalised
• Forms that have not been finalised (i.e. do not contain the integrity stamp) will be rejected by the regulators in the future – date to be confirmed!
• The applicants will still be able to include additional digital signature(s) into the finalised form (exported pdf)
• It will not be possible to include an image of a signature or an 'adobe signature' to the form after the stamp is included
• There is no integrity stamp in the ‘legacy’ interactive pdf eAFs

If you have any question please contact plm.valuestream@ema.europa.eu or raise a request in the EMA Service Desk..

AND

PLM Portal FHIR XML version upgrade

The PLM portal FHIR XML version was updated to 2.2.1. The new version introduces the following change: the <meta> node will contain a new profile value (<profile value=http://ema.europa.eu/fhir/definition/fhir-export/2.2.1.0 />) and the "Bundle-variation" will lose the 4th digit in the XML.

The Release notes can be found here.

26-02-2025

Planned maintenance of eSubmission systems on 4 March 2025, 18:00 CET

Due to planned maintenance, improvements in the Delivery File User Interface and for the Multi Factor Authentication go-live in Common Repository (relevant for NCAs only) and PSUR Repository (relevant for NCAs only), the following eSubmission systems will not be available on Tuesday 4 March 2025, between 18:00 and 22:00: Common Repository (Web User Interface and API), PSUR Repository (Web User Interface and API), Gateway Filehandler, Delivery File User Interface.

For any further information, please contact EMA Service Desk.

And

Planned maintenance of Common Repository on 27 January 2025, 18:00 CET

Due to planned maintenance and in preparation to the MFA activation, the following eSubmission systems will not be available on Thursday 27 February 2025, between 18:00 and 22:00: Common Repository Web User Interface and Common Repository API (both applicable for NCAs only).

For any further information, please contact EMA Service Desk.

And

Planned maintenance of PSUR Repository (Industry access) on 28 January 2025, 18:00 CET

Due to planned maintenance, the PSUR Repository (Industry access) will not be available on Friday 28 February 2025, between 18:00 and 20:00.

For any further information, please contact EMA Service Desk.

20-02-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release Notes reflecting bug fixes and updates to web eAF made in the version 1.1.1.4 released to production on 18 February 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

18-02-2025

ESMP: full scope of ESMP functionalities live on 29 January

As of 29 January 2025, the European Shortages Monitoring Platform (ESMP) is fully operational . In addition to the routine shortage reporting by marketing authorisation holders (MAHs) of centrally authorised products (CAPs), launched in November 2024, the full scope of functionalities of the ESMP is available for crisis and MSSG-led preparedness reporting, for both MAHs and national competent authorities (NCAs). These newly released functionalities will be active in ESMP in crises and preparedness situations for affected MAHs of CAPs and non-CAPs according to the list of medicines published for the specific situations.

The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA.

A dedicated training session for all MAHs will be held on 19 February 2025 from 10:00-12:30 CET. Registration is available here (MAH training registration - WebEx) and more information is available on the training event page on EMA's corporate website. The session will be live broadcast and a recording will be published on the event page.

Further, EMA organises a Q&A session for CAP MAHs on the routine CAP shortage reporting functionalities on 25 February 2025, 10:00 - 11:00 CET. Find more information here on the Q&A clinic (event page) and registration is available via this link (Q&A for CAP MAHs - WebEx). The session will be recorded, and the recording will be made available on the event page.

Finally, please note that all relevant and continuously updated ESMP materials can be found on the ESMP webpage on the EMA website.

13-02-2025

Production go-live for submissions of human variations web-based eAFs for non-CAPs

As previously announced through our Product Lifecycle Management (PLM) newsletter (27/01/2025) the EMA is pleased to confirm as of Tuesday 11 February 2025, the human variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the PLM Portal.

Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now available for use for all procedure types, there are some technical limitations, and in these cases the applicants are requested to use the interactive pdf forms.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

11-02-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.1.3 released to production on 3 February 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

And

PLM Portal FHIR XML version upgrade

The PLM portal FHIR XML version was updated to 2.2.0, however no change affecting the web-based eAF XML was introduced. The Release notes can be found here.

05-02-2025

Planned maintenance of the Common Repository on 5 February 2025

Due to planned maintenance, the Common Repository (User interface and API) will not be available on Wednesday 5 February 2025, between 18:00 and 20:00. For any further information, please contact EMA Service Desk.

03-02-2025

PMS User Interface edit functionalities now live for Industry users!

The Product Management Service (PMS) User Interface (PUI) edit functionalities - live on the Product Lifecycle Management (PLM) portal - are now available for Industry users.

Note that the write access is for now limited to pack size and manufacturer data for non-Centrally Authorised Products* (non-CAPs). This data is indeed required for the shortage reporting via the European Shortages Monitoring Platform (ESMP), which went live with full functionalities on 29 January 2025.

This milestone builds on the previous go-live of the PMS Application Programming Interface (API) in read-only mode (for Marketing Authorisation Holders (MAHs) on 3 July 2024, for H&V National Competent Authorities (NCAs) in September 2024 and for all NCAs in December 2024) and the launch of the PUI in read-only mode for CAPs and non-CAPs (respectively on 31 May 2024 and 19 September 2024).

Please consult this news article for full PMS roadmap and a recap of key current and future actions for MAHs.

• Training webinar: EMA held a public webinar on 28 January 2025 to showcase PMS released PUI edit functionalities (enrichment process). Consult the event web page to access presentation and recording.
• Weekly Q&A clinics on PUI & API in February:
  • 4 February 11:00-11:45 (CET) – registration link
  • 13 February 10:30-11:15 (CET) – registration link
  • 18 February 11:00-11:45 (CET) – registration link
  • 25 February 11:00-11:45 (CET) – registration link

• PUI registration guide: support in completing the steps needed to gain access to the PUI.
• PUI navigation guide: support in navigating across the pages of the PUI.
• PUI known issues document: details of all known issues in the PUI and workarounds where available.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

29-01-2025

Updated eAF 1.27.0.0 Human Variation form

The Human Variation form v1.27.0.0 was updated on the 29 January 2025. The change follows the recent update of the new variation regulation; in the Declaration section in the parallel procedures sub-section, the table with the product/procedure details has been removed.

It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes will be updated and published in the relevant section of the eAF page.

21-01-2025

Updated PLM Portal eAF Release notes now available

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.1.2 released to production on 20 January 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

AND

eCTD 3.2.2 - validation criteria 8.1 to be updated

In the most recent validation criteria (version 8.1) for EU eCTD M1 specification, the rules 15.11 and 15.12 referring to the tracking table being mandatory for all submission types were updated. However, these rules do not apply to EDQM submissions, and therefore a further communication and potential update of the EU eCTD M1 package will be published. In the meantime, for EDQM submissions, you can use the previous validation criteria package (7.1).

14-01-2025

Updated version of the "EU eCTD v4.0 Controlled Vocabularies" (.xml format)

An updated version of the EU eCTD v4.0 Controlled Vocabularies is now available here. The updated package contains the missing list (territorial authority) and the unused list was removed (dosage form category).

13-01-2025

Planned maintenance of eSubmission systems on 14 January 2025, 18:00 CET

Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 14 January 2025, between 18:00 and 19:30: Gateway XML delivery file user interface, Gateway Filehandler, PSUR Repository Web-UI. For any further information, please contact EMA service desk.